When Products Liability Intersects with Malpractice Strategy

Some plaintiffs seek to obviate preemption by arguing not that the warnings were inadequate as approved by the FDA, but rather that the product literature containing such warnings simply was not passed on appropriately to physician or patient as part of the packaging of the device. Manufacturers will dispute the relevance of such argument in cases in which the learned intermediary rule applies, however, if the physician or hospital adequately documented the procedures for transmittal of such materials to the patient prior to or following prescription or implantation of the device. Such evidence may assist with defeating such an argument. In addition, where hospitals or physicians have practices regarding the handling of medical devices and their packaging within the practice or hospital, production of any records demonstrating the chain of custody will also be helpful to invalidate this argument by the plaintiff.

Finally, the success of a product liability claim often turns directly upon who possesses the allegedly defective medical device. Where such a device is explanted from a plaintiff or is taken out of service, it is beneficial to send that device immediately to the manufacturer in order to allow them to check the device to ensure that it is functioning appropriately and to allow for investigation in the event that it is not. If litigation commences and a physician or hospital is still in possession of the device at issue, allowing the manufacturer to examine and test the device as soon as possible will allow them to preserve important evidence to the benefit of all parties. The manufacturer will often allow an expert for the medical provider to be present for any such investigation or testing upon request, and allowing for the examination and preservation of the device's condition as early as possible reduces the risk that beneficial information that might otherwise be obtained will be lost due to deterioration or mishandling.